RelieVRx headset for Pain, Postoperative

1
Effectiveness
1
Safety
Geisinger South Wilkes Barre, Wilkes-Barre, PA
Pain, Postoperative+3 More
RelieVRx headset - Device
Eligibility
18+
All Sexes
Eligible conditions
Pain, Postoperative

Study Summary

This study is evaluating whether a virtual reality headset may help reduce pain and opioid use following knee surgery.

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Eligible Conditions

  • Pain, Postoperative
  • Joint Diseases
  • Opioids Use
  • Arthropathy of Knee

Treatment Effectiveness

Study Objectives

This trial is evaluating whether RelieVRx headset will improve 2 primary outcomes and 8 secondary outcomes in patients with Pain, Postoperative. Measurement will happen over the course of 1 day.

1 day
Post-anesthesia care unit length of stay
12 months
Clinic and emergency department visits
Inpatient readmissions for uncontrolled pain
KOOS Jr. score
Number of surgical complications
Veterans RAND 12 Health Survey (VR-12) physical component score
7 days
Hospital length of stay
Time to initial ambulation
90 days
acute postoperative pain
opioid consumption

Trial Safety

Trial Design

2 Treatment Groups

Standard of care group
Standard of care + RelieVRx group

This trial requires 100 total participants across 2 different treatment groups

This trial involves 2 different treatments. RelieVRx Headset is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Standard of care + RelieVRx groupReceive standard of care for pain management, plus RelieVRx headset
Standard of care group
Drug
Receive standard of care for pain management, do not receive RelieVRx headset

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 12 months for reporting.

Closest Location

Geisinger South Wilkes Barre - Wilkes-Barre, PA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Subject is ≥ 18 years old
Subject is willing and able to read, comprehend, and sign the study informed consent form in English prior to study specific procedure
Subject is scheduled for Total Knee Arthroplasty (TKA) surgery
Subject has a score of 1-3 based on the American Society of Anesthesiologists Physical Status Classification System
Subject attended the pre-op Total Joint Arthroplasty Patient Education class (Proven Recovery Program©)
Subject agrees to be enrolled in Force Therapeutics, a web-based, digital rehabilitation and education program
Subject has family member or community support during post-surgical recovery period

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is pain, postoperative?

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Pain is a common and significant issue for an operation. In this country, only 25% of patients have postoperative pain managed appropriately. However, in most cases, the pain is treated on site when appropriate.

Unverified Answer

How many people get pain, postoperative a year in the United States?

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Almost half of Americans in the United States (48.5%) report they had postoperative pain one year after surgical procedures in 2010. About 13 million Americans report postoperative pain in 1 to 6 day postoperative period. The current study suggests nearly half of patients (46.2%) report pain for postoperative period that begins the following day postoperatively and extends to the 1-year postoperative period.

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Can pain, postoperative be cured?

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Patients often report excessive and chronic postoperative pain shortly after surgery for abdominal hysterectomy. This pain can be managed aggressively by using multimodal analgesia for both acute and chronic pain.

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What are the signs of pain, postoperative?

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Pain is not always obvious and can be subtle in the early postoperative period, especially if there were previous surgeries. Pain typically worsens at night and improves in the wake of light or sound. It can be hard to tell the difference between shoulder or low [back pain](https://www.withpower.com/clinical-trials/back-pain). In most cases, it is possible to obtain information to assist in making the diagnosis. If the pain persists for longer than one or two days, then follow-up visits will be necessary.

Unverified Answer

What are common treatments for pain, postoperative?

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There are a number of effective treatments for a variety of postoperative pain. The American Pain Society has published recommended practice guidelines on postoperative pain. For postoperative pain, opioids are commonly used and are effective.

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What causes pain, postoperative?

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Pain following surgery is often a functional experience, in which the patient learns to use compensating strategies in response to pain. Pain in the early phase after surgery may be due to normal physiological responses, and, given that these responses diminish as time passes after surgery, this pain may be interpreted as a pathology, as may be the case for post-operative pain seen in chronically ill patients. The latter is often thought to be due to neuropathic pain. Such an interpretation often ignores the importance of interactions with the patient and the family, which can lead to distress and pain-related distress.

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Does pain, postoperative run in families?

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Findings from a recent study indicate that in this study cohort, none of the observed associations corresponded to any previously described genetic contribution. As pain, postoperative run in families share common genetic etiology with chronic postoperative pain, the associations reported here could reflect a common etiology for both diseases.

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What is the primary cause of pain, postoperative?

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Pain may be caused by a variety of factors, in which psychologic factors, pain perception and processing, neuroanatomy, and pain management are important in this area. Clinicians must evaluate all factors in the postoperative patient carefully in a multidisciplinary setting. Appropriate use of pain management can reduce postoperative pain in otherwise healthy patients.

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How serious can pain, postoperative be?

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Pain is quite severe compared with postoperatively, postoperative pain has a wide range and most patients who had pain experienced serious pain and required more analgesics with no clear indications for pain.

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What is relievrx headset?

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Asking for a second opinion from a qualified expert can be very useful. Relieving symptoms post-surgery may be the least important aspect of treatments for chronic post-surgical pain.

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Is relievrx headset typically used in combination with any other treatments?

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In most instances, the combination used was the relievrx headset with an opioid medication. Because these combinations are very common, clinicians may need to be reminded of their clinical practice when these combinations are used. Therefore, we recommend that clinicians should be aware that these combinations may be a potential opioid interaction in patients with painful postsurgical conditions. Patient education would be a helpful adjunct to this consideration, and a proper informed consent should be obtained.

Unverified Answer

Have there been other clinical trials involving relievrx headset?

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There is no significant evidence to suggest that the use of the Relivex or Relivex 1 is effective in managing various types of acute-onset headache. Relivex can alleviate moderate to severe pain of short duration in patients who are taking NSAIDS for migraine prophylaxis. Relivex has been shown to be effective in relieving mild pain (short period of 1 to 4 days) in patients with chronic pain.

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